Hidrasec Children 30mg Granules for Oral Suspension

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Racecadotril

Fáanlegur frá:

Bioproject Europe Ltd

ATC númer:

A07XA; A07XA04

INN (Alþjóðlegt nafn):

Racecadotril

Skammtar:

30 milligram(s)

Lyfjaform:

Granules for oral suspension

Gerð lyfseðils:

Product subject to prescription which may be renewed (B)

Lækningarsvæði:

Other antidiarrheals; racecadotril

Leyfisstaða:

Not marketed

Leyfisdagur:

2012-05-11

Upplýsingar fylgiseðill

1
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
HIDRASEC CHILDREN 30 MG, GRANULES FOR ORAL SUSPENSION
racecadotril
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their
signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Hidrasec is and what it is used for
2.
What you need to know before you take Hidrasec
3.
How to take Hidrasec
4.
Possible side effects
5.
How to store Hidrasec
6.
Contents of the pack and other information
1.
WHAT HIDRASEC IS AND WHAT IT IS USED FOR
Hidrasec is a medicine for the treatment of diarrhoea.
Hidrasec is used for the treatment of symptoms of acute diarrhoea in
children over three months of age. It should
be used together with an abundant liquid intake and the usual dietary
measures, when these measures are not
sufficiently effective on their own to control the diarrhoea, and when
diarrhoea can not be treated causally.
Racecadotril can be administered as a complementary treatment when
causal treatment is possible.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE HIDRASEC
_ _
DO NOT TAKE HIDRASEC
-
If your child is allergic to racecadotril or any of the other
ingredients of Hidrasec. (listed in section 6).
-
If you have been told by your doctor that your child has intolerance
to some sugars, ask your doctor
before you give Hidrasec to your child.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before giving Hidrasec to your child
if :
- Your child is under three months of age,
- There is blood or pus in your child stools and if he/she has fever.
The cause of the diarrhoea may be abacterial
infection that should be treated b

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hidrasec Children 30mg Granules for Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 30 mg of racecadotril.
Each sachet contains 2.9g of sucrose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Granules for oral suspension.
White powder with characteristic apricot smell.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Complementary symptomatic treatment
of acute diarrhoea in infants (older than 3 months) and in children
together
with oral rehydration and the usual support measures, when these
measures alone are insufficient to control the clinical
condition, and when causal treatment is not possible.
If causal treatment is possible, racecadotril can be administered as a
complementary treatment.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Hidrasec Children is administered via the oral route, together with
oral rehydration (see section 4.4).
Hidrasec Children 30 mg is intended for children
13 kg.
The recommended dose is determined according to body weight: 1.5 mg/kg
per dose (corresponding to 1 to 2 sachets),
three times daily at regular intervals.
In children from 13 kg to 27 kg
:one 30 mg sachet 3 times daily.
In children of more than 27 kg
:two 30 mg sachets 3 times daily.
The duration of treatment in the clinical trials with children was 5
days. Treatment should be continued until two
normal stools are recorded. Treatment should not exceed 7 days.
There are no clinical trials in infants under 3 months of age.
SPECIAL POPULATIONS:
There are no studies in infants or children with renal impairment or
hepatic impairment (see Section 4.4).
Caution is advised in patients with hepatic or renal impairment.
The granules can be added to food, dispersed in a glass of water or in
the feeding-bottle, mixing well and followed by
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